Background: Paravalvular leaks (PVLs) after transcatheter aortic valve replacement have a significant prognostic impact, and valve oversizing, particularly with self-expanding valves, may prevent postprocedural PVL occurrence. Recent iterations of the Evolut valve system are intended to reduce PVL, but the effects of oversizing with such valves on PVL are largely unknown. We aimed to assess, in a real-world contemporary setting, the impact of Evolut valve oversizing on PVL after transcatheter aortic valve replacement.

Methods: This was a multicenter observational ambispective study of patients undergoing transcatheter aortic valve replacement with the Evolut PRO/PRO+/FX valves. Aortic annulus perimeter, as determined by multidetector computed tomography, was used to estimate the oversizing degree. The primary end point was the presence of PVL (mild/moderate-severe), as determined by echocardiography at hospital discharge. Secondary end points included in-hospital outcomes as defined by the Valve Academic Research Consortium-3 recommendations.

Results: A total of 762 patients were included (Evolut PRO/PRO+/FX, 55.5%/34.8%/9.7%), and the median valve oversizing was 20 (17-25)%, with no differences in baseline characteristics between low (≤20%, n=381) and high (>20%, n=381) valve oversizing recipients. In-hospital mortality and stroke rates were 2.4% and 4.3%, respectively, with no oversizing-related differences in clinical outcomes. Permanent pacemaker rates were similar in patients with low (19.4%) and high (15.8%) valve oversizing, P=0.21. PVL was found in 35.6% of patients (mild: 32.6%, moderate-severe: 3.0%), with a higher incidence of PVL in patients with low (40.9%) versus high (30.2%) oversizing, P=0.002. In a multivariable analysis, a higher oversizing degree was associated with a lower risk of PVL (odds ratio, 0.95 [0.92-0.99] for each 1% increase in oversizing, P=0.006).

Conclusions: In transcatheter aortic valve replacement with recent Evolut valve iterations (PRO/PRO+/FX), a higher oversizing degree was associated with a lower frequency of PVL without increasing the risk of other complications (including permanent pacemaker). These data suggest that a low degree of valve oversizing should be avoided when using Evolut valves, particularly in borderline cases.

Keywords: echocardiography; hospital mortality; incidence; odds ratio; stroke.

背景： 经导管主动脉瓣置换术后的瓣周漏（PVLs）对预后有重要影响，而瓣膜过度放大，特别是使用自扩张瓣膜时，可能防止术后发生PVL。Evolut瓣膜系统的最新版本旨在减少PVL的发生率，但此类瓣膜的过度放大对PVL的影响尚不明确。我们旨在评估在现实世界中当前环境下，Evolut瓣膜过度放大会如何影响经导管主动脉瓣置换术后的PVL。

方法： 这是一项多中心观察性前瞻与回顾相结合的研究，涉及接受Evolut PRO/PRO+/FX瓣膜进行经导管主动脉瓣置换术的患者。通过多探测器计算机断层扫描确定升主动脉窦周径，以估算过度放大程度。主要终点是在出院时通过超声心动图检查是否存在PVL（轻度/中重度）。次要终点包括根据Valve Academic Research Consortium-3建议定义的住院期间结果。

结果： 共有762名患者参与研究，其中Evolut PRO/PRO+/FX瓣膜使用比例为55.5%/34.8%/9.7%。中位瓣膜过度放大程度为20（17-25）%，低度（≤20%，n=381）和高度（>20%，n=381）瓣膜过度放大接受者在基线特征上没有差异。住院期间死亡率和卒中的发生率分别为2.4% 和 4.3%，临床结果无与过度放大相关的差异。低度（19.4%）和高度（15.8%）瓣膜过度放大的患者永久起搏器植入率相似，P=0.21。PVL在35.6%的患者中被发现（轻度：32.6%，中重度：3.0%），低度（40.9%）和高度（30.2%）过度放大的患者中PVL发生率较高，P=0.002。在多变量分析中，较高的瓣膜过度放大程度与较低的PVL风险相关（每增加1％过度放大的优势比为0.95 [0.92-0.99]，P=0.006）。

结论： 在使用最近版本的Evolut瓣膜进行经导管主动脉瓣置换术（PRO/PRO+/FX）时，较高的瓣膜过度放大程度与较低频率的PVL相关，并且不会增加其他并发症的风险（包括永久起搏器）。这些数据显示，在使用Evolut瓣膜时应尽量避免低度的瓣膜过度放大，尤其是在边缘病例中。

关键词： 超声心动图；住院死亡率；发生率；优势比；卒中。